Please use this identifier to cite or link to this item: https://www.arca.fiocruz.br/handle/icict/27805
Title: Validation of a virus neutralization potency test in BHK-21 cells for rabies immunoglobulins in a two-center study
Authors: Moura, Wlamir Corrêa de
Gallina, Neuza Maria Frazatti
Fuches, Regina Maria Mourão
Romijn, Phyllis Catharina
Leite, José Paulo Gagliardi
Affilliation: Fundação Oswaldo Cruz. Instituto Nacional de Controle de Qualidade em Saúde. Departamento de Imunologia. Rio de Janeiro, RJ. Brasil / Fundação Oswaldo Cruz. Instituto Nacional de Controle de Qualidade em Saúde. Programa de Pós-Graduação em Vigilância Sanitária. Rio de Janeiro, RJ, Brasil.
Instituto Butantan. São Paulo, SP, Brasil.
Instituto Butantan. São Paulo, SP, Brasil.
Secretaria de Saúde do Estado do Rio de Janeiro. Rio de Janeiro, RJ, Brasil.
Fundação Oswaldo Cruz. Instituto Oswaldo Cruz. Laboratório de Virologia Comparada. Rio de Janeiro, RJ. Brasil.
Abstract: A rabies virus neutralization potency test (VNPT), adapted to microplates from the rapid fluorescent focus inhibition test (RFFIT) for rabies therapeutic immunoglobulin potency evaluation, was standardized and validated in a two-center study in Brazil. The two institutes involved in the study were: Instituto Nacional de Controle de Qualidade em Saúde (Fundação Oswaldo Cruz) and Instituto Butantan. Two equine rabies immunoglobulin samples, all diluted to 1IU/ml, were tested against the WHO 2nd Rabies Human Ig International Standard. Four dilutions of the samples and standards were tested with the VNPT. The potency of the samples was calculated in IU/ml using the probit method; linearity, accuracy, repeatability (intra-assay variation), intermediate precision (inter-assay variation) and reproducibility (inter-laboratory variation) were assessed to evaluate the reliability of the VNPT. Laboratories were arbitrarily coded as Laboratory A and Laboratory B. The following results were obtained with the International Standard: (a) linearity, the overall coefficient of correlation of the dose-response curve was -0.97; (b) accuracy, % error of -0.70 (IU/ml); (c) repeatability, 17.06% (Laboratory A) and 11.61% (Laboratory B); (d) intermediate precision, 16.99% (Laboratory A) and 22.05% (Laboratory B); (e) reproducibility, 14.5%. The final conclusion was that VNPT presents satisfactory linearity, accuracy, repeatability, intermediate precision and reproducibility and is a reliable and suitable method by which to evaluate rabies immunoglobulin potency.
Keywords: Rabies
Virus neutralization test
RFFIT
Validation
keywords: Raiva
Teste de neutralização de vírus
Validação
teste rápido de inibição do foco fluorescente
Issue Date: 2008
Publisher: Elsevier
Citation: MOURA, Wlamir; et al. Validation of a virus neutralization potency test in BHK-21 cells for rabies immunoglobulins in a two-center study. Journal of Virological Method, v.154, p. 7–13, 2008.
DOI: 10.1016/j.jviromet.2008.09.010
ISSN: 0166-0934
Copyright: restricted access
Appears in Collections:IOC - Artigos de Periódicos

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